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Job Details

Director/Sr. Director Supply Chain Management

Location
San Diego, CA, United States

Posted on
Mar 01, 2022

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Job Summary:

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With substantial experience in the pharmaceutical or biotech industry, the Director/Sr. Director, Supply Chain Management will lead MEI’s Supply Chain team to develop and execute global supply chain strategies aligned with corporate and department goals for MEI Pharma’s clinical trial materials (CTM) and commercial products. The incumbent will oversee all aspects of clinical and commercial supply chain planning, labeling and secondary packaging, and logistics for MEI’s drug development studies and commercialization to ensure reliable, compliant, cost effective, and on-time product supply. As the head of the supply chain management and reporting to our VP of Technical Operations, the ideal candidate will have a background and experience specific to pharmaceutical or biotechnology products, the unique supply chain challenges present in a GMP environment, and commercial launches.

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Role and Responsibilities (Include but not limited to):

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  • Lead Supply Chain function in team building, staff planning, training, couching, and performance management. Mentor and develop team members. Contribute to development and execution of Technical Operations strategies and plans.
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  • Manage Clinical & Operation Planning process to support clinical study teams with study drug supply demand forecasting and logistics for all clinical trials. Work closely with Clinical Operations and Project Management to plan and define clinical study deliverables, timelines, assumptions, and parameters.
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  • Manage all CTM supply activities for timely delivery, resupply, Interactive Response Technology system configuration and operations, returns, reconciliation, and destructions. Track study timelines and generate status reports to ensure alignment with specific study plans and overall clinical development plan.
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  • Establish Sales and Operations Planning process and lead planning and execution of commercial supply chain activities and product launch readiness by partnering with Commercial Operations and other internal and external stakeholders.
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  • Direct clinical and commercial Labeling and Secondary Packaging Operations to support all clinical studies and product commercialization. Lead serialization development and implementation for commercial labeling and packaging through CMOs and 3PLs to meet the compliance requirements. Provide expertise with packaging technologies.
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  • Lead and manage global clinical and commercial products logistics and transportation of starting materials, intermediates, bulk products, and finished goods. Work with service providers to identify and quality shipping routes. Work with Quality Assurance (QA) to plan and execute shipping validations.
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  • Serve as functional lead and Subject Matter Expert (SME) for planning, labeling and secondary packaging, as well as supply and distribution on the CMC and commercial launch teams.
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  • Work closely with Pharmaceutical Sciences and CMC to develop and execute both clinical and commercial Master Production Schedules for drug substance, drug product, and finished goods to meet the product demand. Collaborate with QA to ensure timely release of finished goods domestically and internationally.
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  • Oversee supply chain vendors/CMOs/depots/3PLs. Work with Finance and Legal to manage budget, quotes, contracts, purchase orders, and invoicing activities. Forge and sustain respectful and effective partnerships with all service providers.
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  • Establish effective inventory control and product delivery system for both CTMs and commercial products and ensure visibility and accuracy through CROs/CMOs/3PLs.
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  • Work with QA to review and resolve all shipment issues (damage, temperature excursions, non- compliance). Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership.
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  • Provide input to the development of CTM related study documents including protocols, study and pharmacy manuals.
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  • Act as a clinical and commercial supply chain SME in supporting compliance audits, inspections as assist regulatory submissions of briefing books, CTAs, INDs, IMPDs, NDAs, and MAAs.
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  • Prepare regular reports and metrics of KPIs to measure supply chain performance and creatively seek out ways to improve supply chain processes.
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Qualifications:

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  • Ability to develop and execute strategies and plans, anticipate/define problems, collect and analyze data, make recommendations, and execute corrective actions and preventative measures.
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  • Strong leadership and interpersonal skills and the ability to work independently, as well as a member of a team in a collaborative working environment.
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  • Ability to develop effective relationship and partnership with key stakeholders both internally and externally.
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  • Must have exceptional verbal, written, presentation, communication and negotiation skills with exceptional attention to details.
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  • Good culture fit to MEI’s workplace values of Dedication, Shared Commitment, Personal Accountability, Mutual Trust, and Fiscal Discipline.
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Job Requirements and Education:

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  • Bachelor’s degree in science, engineering, or business is required; graduate degree is preferred.
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  • Minimum of 12 years of planning experience in clinical and commercial supply chains in biotech/pharmaceutical industry.
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  • Minimum of 5 years of experience of clinical study and commercial product planning preferred.
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  • Experience and track record of building and leading high-performance supply chain team as well as strategic thinking and effective operational execution.
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  • Global release and distribution logistics experience is required. Must possess import/export expertise including customs, transportation, and regulatory guidelines.
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  • Working knowledge of GMP and pharma industry procedures and regulations.
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  • Familiar with biopharma manufacturing operations including small molecule drug substance and drug product productions as well as cold chain logistics.
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  • Clinical and commercial labeling and secondary packaging experience is required; serialization experience is preferred.
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  • Experience of successful new production and commercial launch.
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  • Proficiency with: Microsoft Word/Excel/PowerPoint/Project software
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  • Ability and willing to travel up to 25% of the time
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  • Based in MEI headquarter in San Diego or remote with ability to travel to the HQ as needed.
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Employment type

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Full time

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ADA Notations:

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  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
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  • Regular communication (hearing/speaking)
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  • Lifting up to 25 lbs
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  • Routine office duties including computer keyboard use
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  • Vision requirements include close vision and ability to focus
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  • Noise conditions range from quiet to moderate
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n,datePosted:2022-03-02T05:40:51 00:00,validThrough:2022-04-01T04:00:00 00:00,employmentType:FULL_TIME,hiringOrganization:{name:MEI Pharma, Inc.,@id:397843,url:****Diego, CA,address:{addressCountry:US,addressLocality:California,addressRegion:California,postalCode:92130,@type:PostalAddress},@type:place},industry:Manufacturing & Production, Supply Chain,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

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